BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 2781509 · Received October 10, 2012

    Report

    Report Number
    3004753838-2012-00283
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    December 1, 2011
    Report Date
    September 14, 2012
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P050012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2012 TO REPORT THAT PATIENT EXPERIENCES RED AND ITCHY SKIN UNDER THE ADHESIVE PORTION OF SENSORS WORN MORE THAN 4 DAYS. PATIENT CONSULTED PHYSICIAN IN (B)(6) 2011. THE PHYSICIAN ADVISED PATIENT TO REMOVE EACH SENSOR AFTER 4 DAYS OF USE. HE ALSO PRESCRIBED USE OF FLUOCINOINMENT CREAM AT SITE OF REDNESS. AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT, PATIENT'S MOTHER STATES THAT THE PATIENT'S RASH RESOLVED WITHIN 1 DAY OF CREAM APPLICATION, AND PATIENT IS NOW REMOVING SENSORS AFTER 4 DAYS OF WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-03

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other